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Acalabrutinib - Generic Drug Details
What are the generic drug sources for acalabrutinib and what is the scope of patent protection?
Acalabrutinib
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Acalabrutinib has ninety-eight patent family members in forty countries.
One supplier is listed for this compound.
Summary for acalabrutinib
| International Patents: | 98 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 31 |
| Clinical Trials: | 49 |
| Patent Applications: | 66 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for acalabrutinib |
| DailyMed Link: | acalabrutinib at DailyMed |
Recent Clinical Trials for acalabrutinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 2 |
| University of Miami | Phase 2 |
| University of Washington | Phase 1/Phase 2 |
Recent Litigation for acalabrutinib
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Acerta Pharma B v. v. Pharmacyclics LLC | 2018-04-18 |
Pharmacology for acalabrutinib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Tyrosine Kinase Inhibitors |
Synonyms for acalabrutinib
| (S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide |
| 1420477-60-6 |
| 4-[8-Amino-3-[(2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-N-2-pyridinylbenzamide |
| 4-[8-amino-3-[(2S)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-N-pyridin-2-ylbenzamide |
| Acalabrutinib (ACP-196) |
| Acalabrutinib (JAN/USAN/INN) |
| Acalabrutinib [INN] |
| Acalabrutinib [USAN:INN] |
| Acalabrutinib(ACP196) |
| ACP 196 |
| ACP-196 |
| ACP-196;Acalabrutinib |
| AK546544 |
| AKOS030526094 |
| BDBM50175583 |
| Benzamide, 4-(8-amino-3-((2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl)imidazo(1,5-a)pyrazin-1-yl)-N-2-pyridinyl- |
| Calquence |
| Calquence (TN) |
| CHEMBL3707348 |
| CS-5356 |
| D10893 |
| DB11703 |
| DS-3326 |
| EX-A881 |
| Example 6 [US20140155385 A1] |
| GTPL8912 |
| HY-17600 |
| I42748ELQW |
| J-690166 |
| KS-000006AD |
| KS-000006AT |
| NCGC00479074-01 |
| s8116 |
| SB19176 |
| SC-41557 |
| SCHEMBL14637368 |
| UNII-I42748ELQW |
| WDENQIQQYWYTPO-IBGZPJMESA-N |
| ZINC208774715 |
US Patents and Regulatory Information for acalabrutinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259-001 | Oct 31, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca | CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259-001 | Oct 31, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Astrazeneca | CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259-001 | Oct 31, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for acalabrutinib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | E041987 | Start Trial |
| Australia | 2004282219 | Start Trial |
| South Korea | 20160093062 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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